The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.
University of Miami
Miami, Florida, United States
RECRUITINGProportion of patients free of clinically relevant skin toxicities
Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.
Time frame: Up to 18 weeks.
SD-16 scores
Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects.
Time frame: Up to 18 weeks.
Functional Assessment of Cancer Therapy-Breast (FACT-B) scores
FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life.
Time frame: Up to 18 weeks.
High-sensitivity C-reactive protein (hsCRP) values
The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.
Time frame: Up to 6 weeks
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